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FDA 510(k), K031831, TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
FDA 510(k), K031831, TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
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510(K) Number: K031831
Device Name: TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Manufacturer: DONALD H WINFIELD
Device Classification Name: Refractometer, Ophthalmic
Regulation Number: HKO
Classification Product Code: KXA
Date Received: 06/13/2003
Decision Date: 12/19/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Manufacturer: DONALD H WINFIELD
Device Classification Name: Refractometer, Ophthalmic
Regulation Number: HKO
Classification Product Code: KXA
Date Received: 06/13/2003
Decision Date: 12/19/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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